BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK ¿ SYRINGE WITH 20 G X 1 1/2 IN

    MDR report key: 6716076 · Received July 14, 2017

    Report

    Report Number
    1213809-2017-00042
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 19, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS INVESTIGATION: DHR REVIEW FOR BATCH #7002808. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7002808 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ONE BAG CONTAINING ONE OPENED 5 ML PACKAGE WAS RECEIVED BY BD (B)(4). THE BATCH # WAS CONFIRMED TO BE 7002808 UPON VISUAL EVALUATION, THE SAMPLE WAS FOUND TO BE MISSING THE NEEDLE SHIELD. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WITH STUCK WITH A 10 ML BD LUER-LOK ¿ SYRINGE 20 G X 1 1/2 IN PRIOR TO USE BECAUSE THE CAP WAS MISSING. NO MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495831 10 ML BD LUER-LOK ¿ SYRINGE WITH 20 G X 1 1/2 IN HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7002808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other